Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence

Effectiveness of Chinese Herbal Medicine for Older Adults With Urinary Incontinence: A Randomized Double-Blind Placebo-Controlled Clinical Trial

This study aims to evaluate the effectiveness and safety of Chinese herbal medicine in improving urinary incontinence symptoms among older adults. Urinary incontinence is a common condition in aging populations that can significantly impact quality of life, yet existing treatments are often limited by side effects or insufficient efficacy.

The primary research question is whether a standardized Chinese herbal formula can reduce the frequency and severity of urinary incontinence compared to a placebo. We hypothesize that participants receiving the herbal intervention will demonstrate greater improvement in urinary symptoms and quality of life measures than those receiving placebo, without significant adverse effects.

To test this hypothesis, a randomized, double-blind, placebo-controlled clinical trial will be conducted. Eligible older adults will be randomly assigned to receive either the herbal treatment or a matched placebo over a defined study period. Outcomes will include validated measures of urinary incontinence severity, frequency of episodes, and patient-reported quality of life.

Potential benefits of this research include generating high-quality evidence on the effectiveness and safety of Chinese herbal medicine for urinary incontinence, which may inform clinical practice and expand treatment options for older adults. If effective, this intervention could offer a complementary or alternative approach with fewer side effects, contributing to improved symptom management and overall well-being in this population.

Study Overview

• Status: Not yet recruiting
• Conditions: Urinary Incontinence (UI)
• Intervention / Treatment: Other: Placebo Control; Other: Chinese Herbal Medicine (CHM) supplement

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Yang, Dr.; Phone Number: 604-599-2286; Email: john.yang@kpu.ca

Study Locations

• Canada
  • British Columbia
    • Richmond, British Columbia, Canada, V6X 3X7
      • Student Traditional Chinese Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Experience symptoms of urinary incontinence (including stress, urge, or mixed incontinence) as confirmed by clinical assessment or validated screening tools.
• Able to understand the study procedures and provide informed consent.
• Willing and able to comply with study requirements, including attending study visits, and completing questionnaires.
• Stable general medical condition that, in the opinion of the investigator, does not interfere with participation in the study.
• Not currently participating in another interventional clinical trial that could affect urinary incontinence outcomes.

Exclusion Criteria:

• Inability to provide informed consent due to severe cognitive impairment or dementia.
• Known allergy or hypersensitivity to any component of the Chinese herbal medicine formulation.
• Presence of severe, unstable, or uncontrolled medical conditions that may pose a safety risk or interfere with participation, as determined by the investigator.
• Active urinary tract infection at the time of screening (eligible for reconsideration after treatment if appropriate).
• Current use of treatments for urinary incontinence that cannot be safely maintained at a stable dose throughout the study period.
• Significant neurological or urological conditions that severely affect bladder function, unless stable and deemed appropriate by the investigator.
• Participation in another interventional clinical trial that could influence study outcomes or participant safety.
• Any other condition that, in the opinion of the investigator, would compromise participant safety, study adherence, or data integrity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Placebo	Other: Placebo Control; Placebo Control
Experimental: Chinese Herbal Intervention; Standardized Chinese herbal medicine	Other: Chinese Herbal Medicine (CHM) supplement; Chinese Herbal Medicine (CHM) supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).	Primary outcomes will focus on the frequency and severity of urinary incontinence episodes, measured using validated questionnaires. Min = 0 and Max = 6, with higher scores indicating more frequent/severe urinary incontinence.	From enrollment to approximately week 4.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Incontinence Quality of Life Questionnaire (I-QOL)	Secondary outcomes include quality of life, symptom distress, and any adverse events. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transformed to a 'Scale score' ranging from 0-100 points for ease of interpretation: Scale score = (sum of the items - lowest possible score)/possible raw score range X 100.	From enrollment to approximately Week 4.

Collaborators and Investigators

• Sponsor: Kwantlen Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 2, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Older Adults; Traditional Chinese Medicine; Urinary Incontinence; Herbal Treatment; Stage IV Clinical Trial
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Rab geranylgeranyltransferase
• Other Study ID Numbers: KPU REB # 2022-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IDP) will not be shared to adhere to the requirements of our Research Ethics Board Approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No